GxP Validation Lead : QA Life Sciences (Onsite)

GxP Validation Lead : QA Life Sciences (Onsite)

Cognizant Technology Solutions is seeking a \"GxP Validation Lead : QA Life Sciences(Onsite)\" to join our team of IT professionals in a permanent role. If you meet our background requirements and skills and are seeking an opportunity with these skills and expertise, here is the ideal opportunity for you!

About Cognizant's QEA Practice :

We are the largest Quality Assurance Practice globally servicing 800+ clients. We provide Next Gen QA offerings such as System Modernization Assurance, Business Process Assurance, Quality Engineering, Cloud Platform Assurance, Customer Experience Assurance and Robotic Test Automation. We have been ranked #1 for Market Impact by Everest Group for four consecutive years and ranked #1 for completeness of vision, test advisory and Digital Business Assurance in Gartner Magic Quadrant.

Onsite Location : Boston, MA

Qualifications

QA Lead with about 9 to 12 yrs. of experience :

• Deep Knowledge of GxP Regulations
• Strong understanding of FDA, EMA, MHRA, and other global regulatory requirements (e.g., 21 CFR Part 11, Annex 11, GAMP 5).
• Validation Lifecycle Expertise
• Proficiency in managing the full validation lifecycle : URS, Risk Assessment, IQ / OQ / PQ, Traceability Matrix, and Validation Summary Reports.
• Strong Documentation and Audit Readiness Skills
• Ability to author and review validation plans, traceability matrices, SOPs, and compliance documentation.
• Proven track record in preparing for internal and external audits
• Life Sciences Domain Expertise
• Familiarity with Pharmaceutical Industry
• Strong experience in Clinical and Regulatory domains and systems like Veeva Vault QMS, DMS (Preferred)
• Leadership and Stakeholder Management
• Ability to lead cross-functional teams and coordinate with QA, IT, and business stakeholders.
• Skilled in managing validation deliverables across geographies and time zones
• Risk-Based Validation and Process Optimization
• Experience in risk assessment, deviation handling, CAPA management, and process harmonization.
• Familiarity with Agile, Waterfall, and V-Model SDLC approaches
• Technical Proficiency and Tool Familiarity
• Proficient in tools like HP ALM, JIRA, ServiceNow, SharePoint
• Comfortable with data validation, integration testing, and analytics platforms

Roles & Responsibilities

Work Authorization

Cognizant will only consider applicants for this position who are legally authorized to work in the United States without company sponsorship (H-1B, L-1B, L-1A, etc.).

Salary and Other Compensation

Applications will be accepted until 9 / 8 / 2025. The annual salary for this position is between $71,100 and $112,500, depending on experience and other qualifications of the successful candidate. This position is also eligible for Cognizant's discretionary annual incentive program, based on performance and subject to the terms of Cognizant's applicable plans.

Benefits

Cognizant offers the following benefits for this position, subject to applicable eligibility requirements :

Disclaimer : The salary, other compensation, and benefits information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law.

The Cognizant community :

About us :

Cognizant is one of the world's leading professional services companies, transforming clients' business, operating, and technology models for the digital era. Our unique industry-based, consultative approach helps clients envision, build, and run more innovative and efficient businesses. Headquartered in the U.S., Cognizant (a member of the NASDAQ-100 and one of Forbes World\'s Best Employers 2024) is consistently listed among the most admired companies in the world. Learn how Cognizant helps clients lead with digital at www.cognizant.com

Cognizant is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.

Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.

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